Cliniminds Pharmacovigilance’s Post

Regulatory Framework in Latin America - Drug Regulatory Affairs https://lnkd.in/gWvqybCt #DrugRegulatoryAffairs #PharmaRegulations #PharmaceuticalIndustry #RegulatoryCompliance #FDAApproval #ClinicalTrials #PharmaRegulatory #RegulatoryAffairs #DrugApproval #HealthcareCompliance #RegulatoryUpdates #PharmaExperts #PharmacologicalRegulation #GlobalRegulatoryAffairs #DrugDevelopment #PharmaCompliance #HealthcareRegulations #RegulatoryScience#RegulatoryStrategy #PharmaProfessionals #MedicalDeviceRegulations #USRegulations #EURegulations

Regulatory Framework in Latin America - Drug Regulatory Affairs https://lnkd.in/d8q65vWs #DrugRegulatoryAffairs #PharmaRegulations #PharmaceuticalIndustry #RegulatoryCompliance #FDAApproval #ClinicalTrials #PharmaRegulatory #RegulatoryAffairs #DrugApproval #HealthcareCompliance #RegulatoryUpdates #PharmaExperts #PharmacologicalRegulation #GlobalRegulatoryAffairs #DrugDevelopment #PharmaCompliance #HealthcareRegulations #RegulatoryScience#RegulatoryStrategy #PharmaProfessionals #MedicalDeviceRegulations #USRegulations #EURegulations

*Excited to Share My Achievement! 🎉* I’m thrilled to announce that I’ve completed a course on **Drug Regulatory Affairs**! in EDUFABRICA BY AIIMS DELHI. This certification has equipped me with a deeper understanding of the regulatory framework in pharmaceuticals, ensuring compliance with laws and standards across different markets. Key takeaways include: - Regulatory approval processes for new drugs - Key guidelines from FDA, EMA, and other global regulatory bodies - Ensuring drug safety, efficacy, and quality - Navigating post-marketing surveillance and pharmacovigilance This knowledge is crucial for driving innovations while ensuring patient safety. Ready to apply it in real-world scenarios! #Pharmacy #DrugRegulation #RegulatoryAffairs #Pharmaceuticals #LifelongLearning

This course on regulatory affairs provided a comprehensive overview of regulatory authorities' structures, guidelines for clinical trials, market authorization, pharmacovigilance, and more for drugs, including biologicals and devices, across Asia, Europe, and America. #RegulatoryAffairs #ClinicalTrials #Pharmacovigilance #DrugRegulation

🎓 Hii Connections... Excited to share my recent learning achievements !! I recently attend CPA's live webinar on pharmacovigilance and ADR Reporting: inslights from Government Expert's. The session was incredibly inslightul. drug safety, and adverse effect of drug . #pharmacovigilance #drugsafety #drugs #pharmacy #CPA

Thrilled to have completed the Drug Regulatory Affairs course at PharmaState Academy! Ready to apply new insights and drive compliance in the pharmaceutical industry. #ContinuousLearning #PharmaStateAcademy

Hello connections I am very proud for sharing another achievement with you I have completed 1 month certification course in drug regulatory affairs (DRA) in clini India ,With A grade This course have definitely helped me in understanding a key concepts and skills regarding pharmaceutical drug regulatory affairs. A key skill that I was able to learn from a drug regulatory affairs course is the ability to navigate complex regulatory frameworks and ensure compliance with local and international laws. This includes understanding the drug approval process, preparing regulatory submissions, and communicating effectively with regulatory agencies. Additionally, I have also develop skills in risk assessment, data analysis, and project management within the pharmaceutical industry The skills and knowledge I have able to acquire from this course are as follows ○Regulatory Compliance ○Investigational New Drug (IND) ○New Drug Application (NDA) ○Abbreviated New Drug Application (ANDA) ○Drug master file (DMF) ○Common technical documents (CTD) ○Orange book ○Good Manufacturing Practices (GMP) ○Good Clinical Practices (GCP) ○Pharmacovigilance ○Adverse Drug Reaction (ADR) ○Clinical Trials ○Drug Approval Process ○Biologics License Application (BLA) ○Post-Market Surveillance ○Labeling Requirements ○Risk Management ○Regulatory Dossier ○Market Authorization ○Quality Assurance ○International Conference on Harmonisation (ICH) ○Therapeutic Equivalence ○Reimbursement #regulatoryaffairs #pharmaceuticalindustry #pharmaceuticals #regulatorystrategy #regulatoryintelligence #regulatorylaw #fda #fdaapproval #jobsalerts #pharmaceuticalindustry #pharmajobs #regulatoryaffairs #RegulatoryAffairs #Pharmalnsights #CareerGrowth #PharmaceuticalIndustry #regulatoryaffairs #drugsafetyassociat #regulatoryaffairs #biostatistician #trending #support #professionaldevelopment #skilldevelopment #education #learning #management

Proud to have completed the Pharma Drug Regulatory Course 2024! Enhanced my expertise in: Drug development regulations Compliance and quality assurance Global regulatory landscape Looking forward to leveraging this knowledge in my professional journey. #PharmaRegulatory #ProfessionalCertification"

Dear Valued Client, We would like to bring to your kind notice that the Pharmacovigilance new guidance document, version 2.0, will be effective from February 2025, as introduced by CDSCO with their circular dated: 11 Nov 2024 (CDSCO circular attached with this mail). The Pharmacovigilance new guidance document, version 2.0 sets stricter standards, mirroring EU regulations. Ensuring timely compliance is critical to avoid regulatory hurdles. To align your current pharmacovigilance practices with the updated Regulatory guidance, our seasoned pharmacovigilance experts, with 15+ years of experience, can navigate you through this transition. We offer: Comprehensive gap analysis of your current PV processes Expert guidance on implementing updated regulatory requirements Personalized training for enhanced PV practices Thorough revision of existing PV documents Our extensive expertise spans: Global regulatory requirements  PV operations across multiple countries Proven track record of successful implementations Partnering with us ensures: Seamless compliance with CDSCO's new guidance Enhanced PV processes and documentation Mitigated regulatory risks Optimized resource utilization Stay ahead of regulatory shifts with our expert guidance. Elevate your pharmacovigilance practices to mitigate risks and optimize operations. Reach out to us today to explore customized solutions that ensure regulatory adherence, risk mitigation, and sustainable growth. Best regards,  Sofiya Khan #Pharmacovgilance #Drug Safety #Indian Pharmaceutical's #Pharma manufacturer #Marketing Authorization holder #ADRs #Clinical Research #Drug discovery #Regulatory

🎓 Excited to share that I've successfully completed a comprehensive course in Drug Regulatory Affairs! 💼💊 I've gained in-depth knowledge about the regulatory processes governing pharmaceuticals, ensuring their safety, efficacy, and compliance with legal requirements. 💡 This course equipped me with valuable insights into the intricate world of drug development, approval, and post-market surveillance. 🌐 I'm eager to apply this knowledge in contributing to the pharmaceutical industry's commitment to public health and safety. 🌟 #DrugRegulatoryAffairs #Pharmaceuticals #ContinuingEducation #RegulatoryCompliance